Cleared Traditional

K833166 - PROCEDURE 460 FOR DETERM. OF CHLORIDE

K833166 is the FDA 510(k) clearance for PROCEDURE 460 FOR DETERM. OF CHLORIDE by Sigma Chemical Co.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K833166 · Sigma Chemical Co. · Chemistry device
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Oct 1983
Decision
42d
Days
Class 2
Risk

K833166 is an FDA 510(k) clearance for the PROCEDURE 460 FOR DETERM. OF CHLORIDE. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Chemical Co. devices

Submission Details

510(k) Number K833166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1983
Decision Date October 28, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 39
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K833166.
FLOW-PAC CHLORIDE REAGENT SET
K834333 · American Research Products Co. · Feb 1984
CHLORIDE REAGENT SET
K832438 · Amresco, Inc. · Jan 1984
TECH. RA-1000 SYS SERUM CHLORIDE
K833746 · Technicon Instruments Corp. · Jan 1984
TPTZ CHLORIDE
K820235 · American Monitor Corp. · Feb 1982
CHLORIDE REAGENT
K792605 · Gilford Diagnostics · Jan 1980
ELVI CHLORIDE
K792400 · Volu Sol Medical Industries · Dec 1979